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Clinical study on the improvement of the treatment effect of nasal spray of exosomes derived from induced pluripotent stem cells on autistic children

Clinical research protocol for improving the treatment effect of intranasal spray of exosomes derived from induced pluripotent stem cells on children with autism

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102199
Enrollment
Unknown
Registered
2025-05-11
Start date
2025-05-11
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistic spectrundisorder

Interventions

Dose escalation group:Nasal spray induced pluripotent stem cell-derived exosomes
treatment group:Nasal spray induced pluripotent stem cell-derived exosomes
control group:Nasal spray saline placebo

Sponsors

The First Medical Center of the Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1.The diagnostic criteria for ASD were consistent with the second edition of the Autism Diagnostic Observation Scale (ADOS-2) : 7 points, >=5 years old ADOS score >8 points; 2. Age 3-8 years old, male or female; 3. No known immune deficiency diseases, blood routine, liver, kidney, heart, lung no major functional abnormalities; 4.Clinical study participants and/or guardians can fully understand the informed consent content of this study and voluntarily sign the informed consent

Exclusion criteria

Exclusion criteria: 1.Patients with tumors or tumor history (including hematologic tumors and solid tumors); 2.previous history of severe allergic reaction, blood product allergy; 3.Autism and other mental disorders other than autism spectrum disorders due to active epilepsy, cerebrovascular disease or brain trauma; 4.Situations that other researchers consider inappropriate to be included in the group.

Design outcomes

Primary

MeasureTime frame
social responsiveness scale;Vineland scale score;

Countries

China

Contacts

Public ContactYang Guang

The First Medical Center of the Chinese PLA General Hospital

pangping134@gzy.edu.cn+86 152 8550 5367

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026